Associate Director to Director of Drug Substance

About the role

Structuretx is seeking a highly motivated and experienced professional to fill the position of Associate Director to Director of Drug Substance. This pivotal role is designed for an individual who is passionate about drug development and has a proven track record in the pharmaceutical industry. The successful candidate will be instrumental in leading drug substance development initiatives, ensuring that our projects align with regulatory standards and meet the needs of our clients. This position is based in the vibrant Pudong District of Shanghai, a hub for innovation and biotechnology.

Key facts

What you'll do

• Lead and manage the drug substance development team, overseeing all aspects of project execution from initial concept through to commercialization.
• Collaborate closely with cross-functional teams, including formulation, analytical development, and quality assurance, to ensure seamless integration of drug substance processes.
• Develop and implement strategies for drug substance manufacturing, focusing on optimizing yield, purity, and scalability.
• Ensure compliance with all regulatory requirements and industry standards throughout the drug development lifecycle.
• Conduct risk assessments and implement mitigation strategies to address potential challenges in drug substance development.
• Act as the primary point of contact for clients and stakeholders, providing updates on project progress and addressing any concerns that may arise.
• Mentor and develop team members, fostering a culture of innovation, collaboration, and continuous improvement within the drug substance department.
• Prepare and present technical reports, data analyses, and project updates to senior management and external stakeholders.
• Stay abreast of industry trends, emerging technologies, and regulatory changes that may impact drug substance development.
• Participate in the development of budgets and resource allocation for drug substance projects, ensuring efficient use of company resources.
• Lead troubleshooting efforts for any issues that arise during the drug substance manufacturing process, implementing corrective actions as necessary.
• Drive initiatives to enhance operational efficiency and reduce costs within the drug substance development team.

Requirements

• A Master's degree or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• A minimum of 8 years of experience in drug substance development within the pharmaceutical or biotechnology industry.
• Proven leadership experience, with a track record of managing cross-functional teams and driving project success.
• In-depth knowledge of drug substance manufacturing processes, including small molecules and biologics.
• Strong understanding of regulatory requirements, including ICH guidelines and FDA regulations.
• Excellent problem-solving skills, with the ability to analyze complex data and make informed decisions.
• Exceptional communication skills, both written and verbal, with the ability to convey technical information to non-technical stakeholders.
• Proficiency in project management tools and methodologies, with a demonstrated ability to manage multiple projects simultaneously.
• Strong organizational skills and attention to detail, ensuring high-quality deliverables.

Nice to have

• Experience in a leadership role within a fast-paced startup environment.
• Familiarity with advanced manufacturing technologies, such as continuous manufacturing or process analytical technology (PAT).
• Previous experience working with contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs).
• Knowledge of global regulatory submissions and interactions with regulatory agencies.
• Experience with process optimization and scale-up strategies for drug substance production.

Skills & tools

• Proficient in Microsoft Office Suite (Excel, PowerPoint, Word) and project management software (e.g., Asana, Trello).
• Familiarity with laboratory information management systems (LIMS) and other relevant software tools used in drug development.
• Strong analytical skills, with experience in statistical analysis and data interpretation.
• Ability to work effectively in a team-oriented environment and collaborate with diverse groups of professionals.

Practical notes

• This position is based in Shanghai, Pudong District, and may require occasional travel for client meetings or industry conferences.
• Structuretx offers a dynamic work environment that encourages innovation and professional growth.
• Candidates must be eligible to work in China; visa sponsorship is available for qualified applicants.
• Interested candidates are encouraged to apply through our careers page at [Structuretx Careers](https://structuretx.bamboohr.com/careers/333).

Join Structuretx and be part of a team that is at the forefront of drug development, making a meaningful impact on patients' lives worldwide.